Gluten-Free Food Labeling

In order to carry the gluten-free label, a manufacturer must assert that a product’s gluten level is below the regulated threshold of 20 parts per million.

What foods can be labeled "Gluten free?

The food is inherently gluten free

The food does not contain an ingredient that is a gluten-containing grain (e.g., spelt wheat).

The food does not contain an ingredient that is derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour).If the food is made with small amounts of a gluten-containing grain or ingredients derived from such grains that were not processed to remove gluten, the food may not be labeled gluten free even if the food contains less than 20 ppm gluten.

The food does not contain an ingredient that is derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food.

What products are covered by the rule?

All FDA-regulated packaged foods (including imported foods) and dietary supplements. The rule excludes those foods whose labeling is regulated by the U.S. Department of Agriculture (USDA) and the Alcohol and Tobacco Tax and Trade Bureau (TTB). Generally, USDA regulates the labeling of meats, poultry, and certain egg products (FDA regulates the labeling of shell eggs).

Why didn’t FDA adopt zero ppm gluten rather than less than 20 ppm gluten as one of the criteria for a food labeled gluten-free?

It is about enforcement.The FDA agency relies upon scientifically validated methods for enforcing its regulations. Analytical methods that are scientifically validated to reliably detect gluten at a level lower than 20 ppm are not currently available.

If a person sensitive to gluten eats a product labeled gluten-free and becomes ill or otherwise experiences adverse health effects, can they report this to FDA?